510(k) Report

510(k) · Cleared

Cleared

Duralastic Silicone Tubing

K955433510(k) TraditionalCleared Jan 26, 199659-day reviewClass I21 CFR 878.4200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Allied Biomedical Corp. · KGZ Accessories, Catheter

Cleared on Jan 26, 1996 after a 59-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.

Decided
Jan 26, 1996
Review
59 days
Class
Class I
Product code
KGZ
Recalls
None
Predicates
0

15 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1999: 1 descendant cleared1998: 1 descendant cleared2002: 1 descendant cleared2003: 1 descendant cleared2009: 3 descendants cleared2007: 1 descendant cleared2006: 1 descendant cleared2008: 2 descendants cleared2018: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955433 Duralastic Silicone TubingAllied Biomedical Corp. · 1996
  2. Descendant · cites it directly · 14 of its ownK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
  3. Descendant · 2 generations on · 12 of its ownK982294 Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998
  4. Descendant · 3 generations on · 11 of its ownK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002 · Recalled
  5. Descendant · 4 generations on · 10 of its ownK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
  6. Descendant · 5 generations on · 6 of its ownK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 12002: 12003: 12006: 12007: 12008: 22009: 32013: 12018: 12024: 1
1997high 3 (2009) · low 0 (2000)2026

Most influential descendants

Showing 5 of 15 · See all
  • K972317Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997 · cites it directly14descendants
  • K982294Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998 · 2 generations on12descendants
  • K013243Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1Bioform, Inc. · 2002 · 3 generations on11descendants
  • K033398Laryngeal Augmentation ImplantBioform, Inc. · 2003 · 4 generations on10descendants
  • K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · 5 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955433Duralastic Silicone TubingAllied Biomedical Corp.1996—
+1K972317Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc.1997—
+2K982294Xomed Silicone Pre-Form BlocksXomed, Inc.1998—
+3K013243Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1Bioform, Inc.20021
+4K033398Laryngeal Augmentation ImplantBioform, Inc.2003—
+5K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc.20061

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910
200210
200310
200610
200710
200820
200930
201310
201810
202410
FIG. 1 — Lineage of K955433, 1996–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KGZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972317Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc.199714

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K972317 (Boston Medical Products, Inc., 1997) has gone furthest, with 14 descendants of its own.

How does its category compare?

All KGZ devices

KGZ Accessories, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGZ

FDA has decided no KGZ device since 2007.

Median 510(k) review, days · KGZ

Too few KGZ 510(k)s in any year since 2007 to give a median.

Recalls per year · KGZ

3in 2025

2009: 42010: 22020: 12025: 3
2007high 4 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGZ

30in 2025

2007: 12008: 32009: 72010: 372011: 362012: 172013: 162014: 62015: 202016: 542017: 782018: 1002019: 662020: 1132021: 362022: 882023: 552024: 442025: 30
2007high 113 (2020) · low 1 (2007)2025

MAUDE reports naming product code KGZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—03
20090—47
20100—237
20110—036
20120—017
20130—016
20140—06
20150—020
20160—054
20170—078
20180—0100
20190—066
20200—1113
20210—036
20220—088
20230—055
20240—044
20250—330
20260—0—

More from Allied Biomedical Corp.

9 FDA decisions under this applicant name. See the company

  • K982051Kelocate SheetingAllied Biomedical Corp. · 1998
  • K971481Duralastic Anatomical Nasal ImplantsAllied Biomedical Corp. · 1997
  • K971479Duralastic Anatomical Malar ImplantsAllied Biomedical Corp. · 1997
  • K971478Duralastic Anatomical Chin ImplantsAllied Biomedical Corp. · 1997
  • K971480Duralastic I and Duralastic IIAllied Biomedical Corp. · 1997

Recent decisions in KGZ

The KGZ category page

  • K022306Aart Silicone TubingAesthetic and Reconstructive Technologies, Inc. · 2002
  • K974295Byron Medical Aspiration and Infiltration/Irrigation TubingByron Medical · 1998
  • K973183Wound Drainage HolderR & D Medical Products, Inc. · 1998
  • K942315Navarre Percutaneous Access SetNavarre Biomedical, Ltd. · 1994
  • K896087Palestrant Irrigation and Drainage SetNorth American Instrument Corp. · 1989

https://510kreport.com/device/K955433 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955433: Duralastic Silicone Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955433

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026